Is Rubidium chloride rb 82 approved by the US FDA?

Drugs@FDA lists 2 application product lines for Rubidium chloride rb 82, including CARDIOGEN-82 (Prescription); RUBY-FILL (Prescription).

Are there safety signals or safety updates for Rubidium chloride rb 82?

US FDA: 2 entries (latest 2024-12-23).

Active substance

Rubidium chloride rb 82

US FDA 2
Safety 2

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
CARDIOGEN-82	N/A	injectable · injection	BRACCO	Prescription	29 Dec 1989
RUBY-FILL	N/A	solution · intravenous	JUBILANT	Prescription	30 Sep 2016

Safety signals and safety-related labeling changes

US FDA 23 Dec 2024 CARDIOGEN-82 — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 26 Apr 2019 RUBY-FILL — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions

All safety entries for rubidium chloride rb 82 →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.